510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OOLClass II

Electronic Depth Gauge

21 CFR 888.3030 / Orthopedic
FDA source (opens on fda.gov)

OOL is the FDA product code for Electronic Depth Gauge, a class II device type, regulated under 21 CFR 888.3030. FDA's definition for this code reads: "For measuring the depth of a passageway in bone or tissue, prior to insertion of screws or other hardware. The device is an electronic depth gauge for various medical purposes including, measuring the depth of a passageway in a bone or other tissue. It may enable the proper sizing of screws and implants in medical...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OOL
Device name
Electronic Depth Gauge
FDA definition
For measuring the depth of a passageway in bone or tissue, prior to insertion of screws or other hardware. The device is an electronic depth gauge for various medical purposes including, measuring the depth of a passageway in a bone or other tissue. It may enable the proper sizing of screws and implants in medical procedures.
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OOL

By decision year
1 clearance under product code OOL with a decision year between 2009 and 2009, 2009 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OOL by decision year
YearClearances
20091

Applicants with the most clearances

Product code OOL
Applicants holding the most 510(k) clearances under product code OOL
ApplicantClearances
Eidosmed, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code